Realizujemy projekt finansowany przez NCBiR oraz Unię Europejską.
czytaj więcejBIOSTATISTICS
Our biostatistics team has more than 10 years of experience in
biostatistics, clinical data management, and clinical validation of medical
devices.
The team specializes in statistics and machine learning, building advanced
predictive models used in diagnostic and clinical practice and has experience
in clinical validation of AI algorithms.
More than 10 years of experience in medical image and signal analysis, in
numerous therapeutic areas such as cardiology, oncology and traumatology, and
orthopedics.
Experience in developing:
- decision-making algorithms of AI-based systems for use in
diagnostics and clinics.
- algorithms for automatic segmentation of medical images (MRI, OCT, IVUS,
CT).
- algorithms for automatic qualitative and quantitative analysis of medical
images.
Members of the team have continuous ties to academia and belong to
statistical associations related to data analysis.
MEDICAL IMAGING
Development of the statistical part of research projects, including interim and adaptive analyses. | |
Review of protocol documents for consistency, completeness, and clarity of the statistical part. | |
Prepare a statistical analysis plan and review the statistical analysis plan against the protocol. | |
Conduct statistical analysis and interpret results to support decision-making and perform statistical analyses for clinical studies, including but not limited to Phase I-IV clinical trials, observational studies, meta-analyses, PMS, and PMCF. | |
Development of the statistical part of the DSMB charter or a review of the statistical part of the DSMB charter. | |
Review of the CRF template in terms of statistics, endpoints, and whether they can be counted from the data collected from the CRF. | |
Site support, data cleaning, and quality control processes to ensure data integrity. | |
Consulting on statistics and data analysis. |
Image analysis allows us to extract meaningful information from images through image processing and now computer vision. | |
The latest developments in image analysis come from the realm of machine learning and deep learning, allowing us to provide image data in near real-time. | |
We believe AI can move medical care forward by improving the efficiency of triage to subspecialists and personalizing medicine through tailored predictive models. | |
Imaging work addresses the fundamentals of 2D and 3D image processing, including filtering, segmentation, surface reconstruction, and shape analysis. | |
Extracting meaningful information from medical images and signals can allow us to diagnose earlier and with more accuracy. | |
We can help you apply the principles of image analysis to your own applications or learn about the principles to better inform what is possible in your chosen field. | |
Our work in image processing also includes applications of advanced computation to 3D images, which has resulted in the new real-time therapeutic decision support system for PCI procedures. |
We can provide an independent, transparent data analysis process.
We can audit the study - procedure and statistical analysis.
We will provide a blinded statistician to generate a script for data
analysis without access to information about which drug or therapy is
assigned to which patient.
Calculating an appropriate sample size is an essential part of any clinical
trial.
We provide a professional statistician to determine the sample size
according to the study design, study purpose, and assumptions like
- Distribution of data
- Correlation of observations
- Correlation of endpoints
- Subgroup analysis including
propensity score.
Before starting the study, we provide a review of the CRF template in terms of statistics, endpoints, and whether they can be counted from the data collected from the CRF
We provide ongoing statistical monitoring.
Two types of rules are implemented:
Hard rules - if the Protocol Deviation increases then corrective procedures
are put in place - sending a monitor to the site to find the cause.
Soft
rules - which fall within the standard deviation and allow further
investigation.
We ensure data cleaning.
We provide a three-stage process, involving repeated cycles of screening,
diagnosing, and editing of suspected data abnormalities.
Screening:
Lack/Excess of data
Outliers / Inconsistencies
Strange patterns
Suspect analysis result
Diagnosis:
Errors, missing data
True extreme
True normal
Editing:
Correction
Deletion
Leave unchanged
We can help you understand publications using advanced statistics, as well
as perform complex data analysis.
We can quickly and reliably perform the required calculations, as well as
provide a professional presentation of data and information in tables and
figures.
We assist in formatting and submitting manuscripts to scientific journals,
paying special attention to table and figure formats.
We develop scripts in terms of individual protocol studies. The scripts provide automatic repeatable analysis of collected data.
We do an exploratory data analysis of a study that didn't work out.
We look for reasons why the study didn't work out, whether the assumptions
were wrong, or the methodology chosen.
We provide assistance in writing data acquisition protocols.
We develop automatic or semi-automatic segmentation instead of manual
segmentation, considering:
Repeatability. This means that when it is used on the same data, the result
will not change.
Consistency. The algorithm actually solves the given problem and performs
the task, rather than doing something that is not important. For example, the algorithm
can detect the sick part in all the different scans.
Accuracy, it is very important that the algorithm detects the diseased part
as precisely as possible. Only with accurate data can accurate results be
obtained.
Time
efficiency. Results should be generated as quickly as possible so that the
entire diagnostic process can also be accelerated.
We estimate the correct size of the data set, along with writing a
procedure for dividing it into training, and validation sets, taking into
account the characteristics of the images and the changes in the objects in
them.
So
that the individual changes have a similar distribution in each set.
Members of the Biostatistics and Medical Imaging Team have published more
than 50 PubMed-indexed articles in various fields of medicine, medical technology and
biomedical engineering.
The competence and experience of our team will enable you to design and
conduct a high-quality study.